Director, Global Regulatory Strategy Oncology
Your tasks and responsibilities
The primary responsibilities of this role, Director, Global Regulatory Strategy, Oncology, are to:
- Develop robust Global Regulatory Strategy for complex/high impact programs in the Oncology portfolio that leverages accelerated regulatory approval pathways and other innovative strategies that enable fastest path to first cycle approval;
- Provide guidance and oversight to Global Regulatory Strategists on assigned program that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy;
- Serve as the Global Regulatory Expert for the
assigned program and partners effectively with the Global
Development Leader (GDL)/Early Development Portfolio Lead (EDPL),
Global Clinical Leader (GCL)/Early Clinical Leader (ECL), Global
Project Leader (GPL)/Early Project Leader (EPL) and the Biomarker
Leader to develop strategy documents to support decision making at
Governance committees and for formal meetings with Health
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Advanced technical degree Ph.D., DVM or Pharm D with at least 8 years’ of medical research activities of which 3-5 years include local/ global regulatory experience in related TA area, OR M.S. degree with at least 10 years’ of medical research activities of which 5-7 years include local/global regulatory experience in related TA area, OR B.S. degree with at least 12 years’ of medical research activities of which 10-12 years include local/global regulatory experience in related TA area;
- Expert knowledge of regional and global regulations;
- Demonstrated interactions with local and global health authorities;
- Excellent communication skills, verbal and written, and strong analytical skills;
- Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills;
- A clear understanding of cultural and business needs in leading a diverse team.
- Advanced technical degree Ph.D., DVM or Pharm D in life sciences;
- Experience working on international regulatory strategy and filings.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.